FEATURED EDITORIAL

GUEST CONTRIBUTORS

  • A Biosimilar Applicant’s (Illusory?) Right To Declaratory Relief
    A Biosimilar Applicant’s (Illusory?) Right To Declaratory Relief

    This article explains why having the right and option to seek declaratory relief is still important to a biosimilar applicant despite the patent resolution mechanism provided by BPCIA, examines the limitations on declaratory judgment actions imposed by BPCIA, and discusses recent court cases addressing biosimilar applicants’ rights to declaratory relief.

  • Manual Aseptic Processing: The Last Resort Or The Best Approach?
    Manual Aseptic Processing: The Last Resort Or The Best Approach?

    When weighing the operational and product constraints — batch size, container throughput, cost per unit, equipment utilization, facility footprint, cost per square foot, etc. — it is important to consider all of the options available to provide the most effective processing approach for the product manufacturer and, importantly, the best quality product for patients.

  • 4 Future Scenarios For Cell And Gene Therapy Adoption
    4 Future Scenarios For Cell And Gene Therapy Adoption

    Cell and gene therapies are finally becoming a reality, with hundreds of clinical trials underway and some major therapeutic breakthroughs already reaching the market. In the past year alone, the FDA approved its first gene therapy, Spark’s Luxturna for the treatment of a rare form of vision loss, as well as the first two CAR T-cell therapies, Novartis’s Kymriah and Gilead’s Yescarta, for certain forms of blood cancer. While this certainly marks the beginning of an exciting period in the development of cell and gene therapies — the culmination of decades of development — the future impact of cell and gene therapies is uncertain.

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PHARMA OUTSOURCING WHITE PAPERS

Overview Of A Scale-Up Of A Cell-Based Influenza Virus Production Process Using Single-Use Bioprocessing Equipment Overview Of A Scale-Up Of A Cell-Based Influenza Virus Production Process Using Single-Use Bioprocessing Equipment

The aim of this white paper is to demonstrate how GE Healthcare Life Sciences single-use products can be applied in the field of vaccine manufacturing. The white paper includes a brief discussion around modern vaccine processes, followed by a case study showing the scale-up of upstream and downstream processes for the production of a cell based live attenuated influenza virus using single-use ReadyToProcess technology.

Platform Approach To Purification Of Bacterial Capsular Polysaccharides For Vaccine Production Platform Approach To Purification Of Bacterial Capsular Polysaccharides For Vaccine Production

Capsular polysaccharides (CPS) of encapsulated bacterial pathogens can give rise to an effective immune response in humans, and are commonly used in vaccine production. This whitepaper offers an overview of modern tools and technologies that can facilitate CPS-based vaccine production. An alternative purification approach based on chromatography, replacing many of the ethanol and phenol extraction steps of the traditional process, is also presented. Using the proposed purification platform, 28 different CPS of three different species could be processed to high purity and yield in a secure and environmentally friendly way.

Managing Risk In Biomanufacturing

Commercial, manufacturing, and supply aspects in the biopharmaceutical industry can all be managed in order to mitigate risk. This white paper focuses on how a structured and transparent risk management process can be an ideal way to align the needs of patients with drug manufacturers and their suppliers, regulators, investors, and employees. Read on to learn more about guarding commercial interests, building and managing manufacturing capacity, and preventing supply disruption, and how these things can impact managing risk in biomanufacturing.

9 Reasons To Consider A Single-Use Fermentor

Dedicated Fermentation Technology Replacing Stainless Steel Systems in Bioprocess Markets

How To Survive An FDA Audit

Understanding the FDA audit process, preparing for it and being aware of regulations will help to restore a sense of control and help to ensure the best outcome.

Broaden Analysis Of Compound Factors For Predictive Solubility Solutions

Developed by the FDA, the Biopharmaceutics Classification System helps companies when they file for bioequivalence of dosage forms based on in vitro dissolution testing.

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PHARMA OUTSOURCING APP NOTES & CASE STUDIES

Decision Timeline: Considerations In Selecting An Outsourced Solution

The traditional business model for in-house pharma manufacturing is nearly a thing of the past. More companies are turning to outsourcing to achieve flexibility and efficiency in a highly competitive market. 

Virtue Is Harmony: Using Lab Data Automation To Break Down The Silos In Pharma R&D

In a scenario where manufacturing processes move to a continuous flow, analyzers are producing data simultaneously, necessitating real-time processing and cloud-based tools for data management.

The Unique Needs Of The HPAPI Market: Are You Prepared?

To take advantage of the growing HPAPI market, a company must have the proper controls in place to safely handle these potent compounds and successfully bring its drug to market.

Temperature-Controlled Thermal Container – Quick Packout

By employing sleeves containing phase-change material, Minnesota Thermal Science increases thermal protection by at least 15%. Packing shippers with temperature-control devices and insulation materials consistently and quickly can be a challenge. 

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ABOUT US

Outsourced Pharma provides comprehensive analysis and exclusive content from thought leaders for the advancement of global outsourcing of drug development and manufacturing. We offer readers of our website and participants of our conferences – our Outsourced Pharma community – a deeper exploration and understanding of the relationships between pharmaceutical and biotechnology organizations with their service providers, and an open channel of communication.

About Outsourced Pharma Conferences
Outsourced Pharma Conference & Exhibition is a vibrant forum for thought-leadership and the application of best practices for professionals engaged in outsourcing drug development and manufacturing. These conferences and exhibitions form a community for networking and discussing topics most relevant to sponsor-provider partnerships and supply-chain management, within an open format that promotes panel and attendee interaction.

About OutsourcedPharma.com
OutsourcedPharma.com provides comprehensive analysis of global outsourcing, the biotechnology and pharmaceutical industries, and their intersection with the overall life sciences and healthcare markets. We offer readers a deeper exploration and understanding of the relationships between service providers and their bio and pharma sponsors.

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INDUSTRY INSIGHTS

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OUTSOURCING EVENTS

4th Annual 340B Manufacturer Summit August 21 - 22, 2018
Arlington, VA)
Bio/Pharma Forum on the State of Medicare Reform August 21, 2018
Arlington, VA)
Understanding & Implementing The Revised NIH & FDA Clinical Trial Protocol Template August 21 - 21, 2018
1pm-2:30pm EST, Online Training)
Duration:  90 Minutes
Price:  $299 - Includes Bonus Handouts!
Reacting to “Human Error” – Moving Beyond “Retraining” As A Response August 22 - 22, 2018
1pm-2:30pm EDT, Online Training)
Price:  $299 - Includes Bonus Handouts!
Measuring Medical Affairs Success – Identifying the Key Performance Indicators (KPIs) for Successful Teams August 24 - 24, 2018
1:00 PM - 2:00 PM EDT)
Duration:  60-Minutes
Price:  $199 - Includes Bonus Handouts!
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